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Service Line: Optimal Use

Issue Number: volume 6, no. 1c

Publication Date: March 2017

Report Length: 22 Pages

CADTH OPTIMAL USE REPORT

Interventions for the Treatment of Obstructive Sleep Apnea in Adults: Recommendations

OPTIMAL USE REPORT Interventions for the Treatment of Obstructive Sleep Apnea in Adults: Recommendations 2

Cite As: Interventions for the treatment of obstructive sleep apnea in adults: recommendations. Ottawa: CADTH; Mar 2017. (CADTH Optimal Use Report;

vol.6, no.1c).

ISSN: 1927-0127 (online)

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Table of Contents

ABBREVIATIONS .......................................................................................................................................................... 4 SUMMARY OF RECOMMENDATIONS ......................................................................................................................... 5

Technology ................................................................................................................................................................ 6 Policy Question .......................................................................................................................................................... 6

METHODS ..................................................................................................................................................................... 7 DETAILED RECOMMENDATIONS ............................................................................................................................... 7

Rationale .................................................................................................................................................................. 7 Considerations ........................................................................................................................................................... 8

BACKGROUND ........................................................................................................................................................... 10

Research questions ................................................................................................................................................. 10 SUMMARY OF THE EVIDENCE ................................................................................................................................. 11

Clinical Evidence ..................................................................................................................................................... 11 Economic Evidence ................................................................................................................................................. 12 Patient Perspectives and Experiences Evidence ..................................................................................................... 12 Ethical Issues........................................................................................................................................................... 13 Implementation Issues ............................................................................................................................................. 14 Environmental Impact .............................................................................................................................................. 14

RESEARCH GAPS ...................................................................................................................................................... 14 APPENDIX 1: HTERP .................................................................................................................................................. 18

HTERP Core Members ............................................................................................................................................ 18 Expert Members ...................................................................................................................................................... 18 Conflict of Interest .................................................................................................................................................... 18

APPENDIX 2: HTERP DELIBERATIVE FRAMEWORK ............................................................................................... 19


Abbreviations AHI apnea-hypopnea index

CPAP continuous positive airway pressure

EDS excessive daytime sleepiness

GTA genial tubercle advancement

HTA health technology assessment

HTERP Health Technology Expert Review Panel

MAD mandibular advancement device

MMA maxillomandibular advancement

OSA obstructive sleep apnea

PAP positive airway pressure

QALY quality-adjusted life year

QoL quality of life


Summary of Recommendations

Obstructive sleep apnea (OSA) is characterized by a narrowing and collapse

of the upper airway during sleep.1,2

The prevalence of OSA is reported to be

15% in males and 5% in females.3,4

The major symptoms include snoring,

unrefreshing sleep, excessive daytime sleepiness (EDS), lack of

concentration, impaired memory, and lower quality of life.5,6

Aging, the male

sex, and obesity are the main risk factors for OSA.7,8

Untreated OSA is

associated with motor vehicle accidents, cardiovascular disease, stroke,

hypertension, diabetes, cognitive dysfunction, and all-cause mortality.1,6,9-11

The goal of treatment of OSA is to reduce the apnea-hypopnea index (AHI)

— an index used to indicate the severity of sleep apnea — increase blood

oxygen levels, and improve cardiorespiratory indicators. The AHI measures

the number of apnea or hypopnea events per hour.12

Although continuous

positive airway pressure (CPAP) is the standard for treating OSA, between

29% and 83% of patients do not comply with regular device use.13-15

Adherence with oral appliances, including mandibular advancement devices

(MADs), is not as well documented, but is regarded as superior to CPAP

adherence.16,17

Surgical interventions for OSA treatment are invasive

procedures for which evidence of effectiveness and safety is unclear.12

For

patients with mild or asymptomatic OSA, lifestyle interventions such as

exercise programs, diet changes, and positional therapies may be an option

for treatment before proceeding to other interventions.18

Across jurisdictions, OSA is associated with a substantial economic and

societal burden.7,8,19

Currently, public coverage for treatment of OSA varies

widely across Canada, with some provinces supporting CPAP therapy for

OSA patients, but the criteria and type of reimbursement varies.2 No

provincial programs reimburse oral appliance costs while some federal

programs do reimburse eligible patients.

Given the range of clinical presentation, symptoms, and severity,

recommending the most appropriate treatment for OSA patients can be

challenging. To facilitate decision-making, CADTH conducted a health

technology assessment (HTA) on the clinical effectiveness and cost-

effectiveness of interventions for the treatment of OSA in adults. Patient

perspectives and experiences, ethical and implementation issues, and

environmental factors related to therapy selection for OSA in adults were

also considered in an evaluation of the appropriate use of OSA

interventions.20


Technology

Treatment of obstructive sleep apnea (OSA) includes a wide range of

options.21

Continuous positive airway pressure (CPAP) forces air into the upper

airways to prevent soft tissues from collapsing and is considered the gold

standard for the treatment of OSA.12,21,22

Other positive airway pressure

(PAP) technologies, such as autotitrating PAP and bilevel PAP, may be

offered to patients with specific needs.12,21

Another treatment option is nasal

expiratory PAP valves, which are disposable devices that use a patient’s

own breathing to create positive end-expiratory pressure that prevents

airway collapse.23

Oral appliances, including the mandibular advancement devices (MADs) and

tongue-retaining devices (TRDs), can be offered as an alternative to

CPAP.12,24,25

For patients with mild or asymptomatic OSA, lifestyle

interventions such as exercise programs, diet changes, and positional

therapies may be proposed.18

Surgical maxillomandibular advancement (MMA) permanently pulls the lower

jaw forward to create more space and prevent airway collapse.26,27

Genial

tubercle advancement (GTA) is a surgical intervention that removes bone

tissue from the chin and pulls the base of the tongue forward to create more

airway space, and can be performed in conjunction with MMA or other

surgeries to potentially improve therapeutic success.28,29

Policy Question

What is the optimal use of PAP devices, expiratory PAP valves, oral

appliances, surgical interventions, and lifestyle interventions for treatment of

adults with OSA?

1. For patients with mild OSA who are overweight or obese, the Health Technology Expert Review

Panel (HTERP) recommends lifestyle interventions. For patients with mild OSA who are not

overweight or obese, HTERP does not recommend active treatment.

2. For patients with moderate or severe OSA, HTERP recommends continuous positive airway

pressure (CPAP). For patients with moderate or severe OSA for whom CPAP is unacceptable,

oral appliances are recommended.

3. HTERP does not recommend surgical maxillomandibular advancement in patients with OSA,

unless other interventions have failed or are unacceptable to the patient.


Methods

CADTH conducted a HTA to assess the clinical effectiveness, cost-

effectiveness, patient perspectives and experiences, ethical issues,

implementation issues, and environmental impact of PAP devices, oral

appliances, surgical interventions, and lifestyle interventions for the

treatment of OSA in adults.20

The Health Technology Expert Review Panel

(HTERP) (Appendix 1) developed recommendations about interventions for

the treatment of OSA based on the evidence presented in the HTA report.

HTERP members reviewed the evidence, discussed all elements of the

HTERP deliberative framework,30

and developed a consensus-based

recommendation through discussion and deliberation. See Appendix 2 for

details.

Additional information on the HTERP process is found on the HTERP page

of the CADTH website: https://www.cadth.ca/collaboration-and-

outreach/advisory-bodies/health-technology-expert-review-panel.

Detailed Recommendations

The objective of these recommendations is to provide advice for Canadian

health care decision-makers about the optimal use of interventions for the

treatment of OSA of varying severity in adults. These recommendations are

relevant for patients who were diagnosed with any severity of OSA and were

either treatment-naive or previously treated, as measured objectively by

polysomnography or portable monitoring.

1. For patients with mild OSA who are overweight or obese, HTERP recommends lifestyle interventions. For patients with mild OSA who are not overweight or obese, HTERP does not recommend active treatment.

2. For patients with moderate or severe OSA, HTERP recommends CPAP. For patients with moderate or severe OSA for whom CPAP is unacceptable, oral appliances are recommended.

3. HTERP does not recommend surgical MMA in patients with OSA, unless other interventions have failed or are unacceptable to the patient.

Rationale

The results of the clinical review indicate that, while various interventions

may have similar and only marginal effects on improving sleepiness across

mild-to-severe cases of OSA, CPAP may have the largest effect on

improving OSA severity, if patients comply with the therapy. Further, the

clinical and economic data indicate that patients with moderate OSA may

benefit most from MADs, and those with severe OSA may benefit most from

CPAP. More specifically, the results suggest that CPAP is more effective

than MADs for EDS in adults with severe OSA. Although treatment is not

https://www.cadth.ca/collaboration-and-outreach/advisory-bodies/health-technology-expert-review-panel

https://www.cadth.ca/collaboration-and-outreach/advisory-bodies/health-technology-expert-review-panel


recommended in patients with mild OSA, the committee suggested that

treatment may be considered in patients with mild OSA who are

symptomatic.

Surgical MMA, with or without GTA, was the most clinically effective and

cost-effective intervention at a willingness-to-pay threshold of $17,125 per

quality-adjusted life-year (QALY) in patients with very severe OSA. Unlike

other interventions for OSA, this is an invasive procedure. In addition, the

findings on MMA, with or without GTA, were obtained from small,

uncontrolled pre- and post-treatment studies of highly selected patients, and

therefore MMA is not recommended for most patients with OSA.

There were no major adverse events reported for most OSA interventions.

Some of the evidence was deemed to be of high quality, but there are quality

concerns for some studies due to their eligibility criteria, sample sizes, and

uncontrolled study design.

Patient factors that influence whether people seek and commence OSA

treatment are individualized and contextual. People with OSA usually

perform a trade-off between the benefits of OSA treatment and their

discomfort with the intervention. All treatments had some degree of

discomfort, and this discomfort may change over time as patients become

accustomed to the device. There is also a recovery time for surgery. For

some patients, especially those with mild OSA, these feelings of discomfort

were enough of a deterrent that therapy was discontinued. For others, the

physical, mental, and social benefits experienced from using an intervention

for OSA were motivation to continue treatments. For those using CPAP, the

sense of embarrassment and perceived unattractive appearance while using

the device might be a reason for nonadherence. Those with supportive

partners may be able to persevere and continue with treatment, though not

all spouses are supportive. OSA interventions affected patients and their

partners, and decisions regarding treatment may be made within the context

of their relationship, with a consideration of the impact of treatment on the

spouse.

Although there are no ethical concerns inherent with the technologies used

to treat OSA, it can be a challenge for some patients to access some of the

necessary resources, such as sleep specialists and specialized sleep labs.

Considerations

Reimbursement coverage for PAP treatments and oral devices differs across

Canada, while surgery may be covered as a medical act. These variations in

coverage can be a barrier to accessing effective treatments. Choosing an

intervention for specific patients may need to consider the reimbursement

criteria, OSA severity, and patient perspectives.

In the economic evaluation, the findings were relatively insensitive to the

different reimbursement strategies explored. When oral appliances were

expensed out of pocket, they were found to be the most likely cost-effective


intervention for mild-to-moderate OSA. However, a review of patient

perspectives and experience and implementation has highlighted the

financial burden from out-of-pocket costs as an important issue affecting

adherence to treatment.

Trial periods for CPAP with the reuse of devices found to be unacceptable by

others may help determine which patients would benefit the most from

intervention, without an initial investment. Oral appliances and lifestyle

interventions are feasible options for patients for whom CPAP is

unacceptable, especially in less severe cases of OSA.31-33

These

alternatives may be appropriate for patients who do not have access to the

necessary infrastructure (i.e., electricity, clean water, etc.) for specific

treatments.

There was some evidence that the longer the study duration, the lower the

effects of CPAP, MADs, and positional therapy, potentially due to

discontinuation over time. It is also possible that the effects of CPAP and

OAs first peak and then taper, which could also lead to discontinuation over

time. In other words, the level of effect first rises and then falls. The authors

of one study (retrieved after analysis) concluded that improved clinician

communication skills can help support shared decision making and

“motivate patients to try CPAP after the initial visit, and thereafter to improve

long-term adherence”.34

Surgical MMA is invasive and should only be considered if other treatment

options have failed, are unacceptable, or are not affordable, and surgery is

covered as a medical act. In practice, the appropriate surgical procedure for

OSA depends on the site of the anatomical obstruction and a patient’s

anatomical features.

Many patients are nonadherent to therapy primarily for personal and

contextual reasons. Patients experienced discomfort for all interventions, and

this discomfort may change over time as they adjust to the device or recover

from surgery. Patients require support from their health care providers and

their partners and family. Receiving the right information about treatment

choices or how to care for the devices they chose to use is an important

component of supporting patients with OSA and their caregivers. Patients felt

that it was important to interact with a health care professional following

initiation of CPAP, and also expressed a desire for access to professional

support and reassurance at night. Further, patients had to persevere with

treatment, and the intervention had to become part of their routine for those

who could tolerate it.

Although the diagnosis of OSA was beyond the scope of this report,

diagnosis is required to access treatment, making access to publicly funded

diagnostic testing an important consideration in the treatment of OSA.35-37

A

2016 study reported that the AHI determined by a device for home diagnosis

of sleep apnea was comparable with the results of standard

polysomnography. This study suggests that patients may be able to reliably


diagnose sleep apnea at home, possibly increasing access to OSA diagnosis

and subsequent treatment.38

In addition to differences in clinical presentation, such as sleepiness, fatigue,

headache, or mood, men are more commonly reported to be diagnosed with

OSA than women.1 The patient perspectives and experiences review found

that one reason for this could be that women are more likely than men to feel

shame related to snoring and therefore less likely to seek diagnosis.39

As

well, women may not present with “classic” OSA symptoms,40

and OSA

symptoms do not always correlate with severity. Finally, women are more

likely than men to encourage their spouses to be diagnosed, as opposed to

the other way around.41

These findings suggest that OSA could affect

women more often than proposed by current diagnosis rates.

Background

Therapy selection for OSA is based on an assessment of the patient by lab-

based polysomnography or home-based portable monitors.36

An analysis of

the clinical effectiveness and cost-effectiveness and a review of patient

perspectives and experiences, ethical and implementation issues, and

environmental factors were conducted to inform recommendations about the

appropriate use of interventions for the treatment of OSA in adults.

The evidence on clinical and economic effectiveness, patient perspectives

and experiences, ethical and implementation issues, and environmental

factors used for developing this guidance was derived from the CADTH HTA:

Interventions for the Treatment of Obstructive Sleep Apnea in Adults.20

Research questions

1. What are the clinical effectiveness, comparative clinical effectiveness, and safety concerns of PAP devices, expiratory PAP valves, oral appliances, surgical interventions, and lifestyle modifications for the treatment of OSA in adults?

1a. What are the clinical effectiveness, comparative clinical

effectiveness, and safety concerns of PAP devices, expiratory

PAP valve, oral appliances, surgical interventions, and lifestyle for

the treatment of adult patients with different OSA severity (i.e.,

mild, moderate, severe)?

1b. What are the clinical effectiveness, comparative clinical

effectiveness, and safety concerns of interventions for the

treatment of adult OSA patients with or without comorbidities (e.g.,

obesity, hypertension, diabetes)?

2. What is the cost-effectiveness of PAP devices, expiratory PAP valves, oral appliances, surgical interventions, and lifestyle for the treatment of OSA in adults?


3. What are the experiences and perspectives of adult patients, their family members, and their caregivers regarding PAP devices, expiratory PAP valves, oral appliances, surgical interventions, and lifestyle for the treatment of OSA?

4. What ethical issues are raised by providing PAP devices, expiratory PAP valves, oral appliances, surgical interventions, and lifestyle to treat OSA in adults? How should these issues be addressed?

5. What are some of the implementation issues associated with PAP devices, expiratory PAP valve, oral appliances, surgical interventions, and lifestyle for the treatment of OSA in adults?

6. What are some potential environmental impacts associated with PAP devices, expiratory PAP valves, oral appliances, surgical interventions, and lifestyle for the treatment of OSA in adults?

Summary of The Evidence

Clinical Evidence

A systematic review of the literature was conducted, using MEDLINE,

Embase, Cochrane Database of Systematic Reviews, Database of Abstracts

of Reviews of Effects, Cochrane Central Register of Controlled Trials, and

PubMed, for an overview of systematic reviews, meta-analyses, and HTAs,

supplemented by a review of primary studies for areas of gap. In total, 33

systematic reviews and 41 primary studies were included in the overview

and review, respectively. Both involved adults with OSA who were treated

with PAP devices, expiratory PAP valves, oral appliances, surgery, and

lifestyle interventions and assessed on various outcomes, with EDS as the

primary outcome.

CPAP, expiratory PAP, MADs, TRDs, MMA, GTA, weight loss programs, and

positional therapy were all effective at reducing EDS (commonly measured

by the Epworth sleepiness scale) compared with inactive controls or pre-

treatment. Effect sizes were similar across the interventions, except for

people with severe cases of OSA who may benefit more from CPAP than

from MADs, although the difference may not be clinically significant. Based

on an analysis using OSA severity as the outcome, commonly measured by

AHI, effect sizes varied across the interventions, with CPAP showing the

largest effect. For people with severe cases of OSA who are eligible for

surgery, MMA with or without GTA may be effective at improving both EDS

and OSA severity. However, the findings are mostly from small, uncontrolled

pre- and post-treatment studies on highly selected patients and warrant

caution, considering the invasiveness of the procedure and potential adverse

events. Limited evidence was found on other outcomes, such as blood

pressure, cardiovascular events, quality of life, and mortality. The 33

systematic reviews and 41 primary studies were assessed to generally be of

high quality, using accepted quality assessment tools. But concerns were

identified around the study eligibility criteria for the systematic reviews and

small samples and uncontrolled pre- and post-treatment study designs for


the primary studies. The primary studies included in the 33 reviews ranged

widely in their quality.

Economic Evidence

A Markov cohort model was constructed to evaluate the cost-effectiveness of

various treatment strategies in adult patients diagnosed with OSA (i.e.,

76.5% males, 55 years of age) over a patient’s lifetime within a Canadian

health care payer perspective. The effect of treatment in terms of change in

AHI and blood pressure was determined from the clinical review and was

translated to changes in the risk of cardiovascular events and motor vehicle

accidents in the economic model. The primary outcome was cost per QALY

gained in 2016 Canadian dollars. The base-case analysis compared a “no

treatment” strategy against PAP therapy, MADs only, and surgery (i.e., MMA

with or without GTA). A separate scenario analysis was conducted on obese

or overweight patients, in which weight loss would be a suitable treatment

strategy.

Cost-effectiveness of treatment strategies for OSA was found to be

dependent on a patient’s baseline disease severity, as measured by AHI

(i.e., lower AHI equates to less severe OSA). At a willingness-to-pay

threshold of $50,000 per QALY, the order in which interventions were

considered cost-effective by increasing baseline disease severity was: no

treatment (AHI < 15), MADs (15 ≤ AH I≤ 25), MMA with or without GTA (25 <

AHI < 30), PAP therapy (30 ≤ AHI ≤ 32), and MMA with or without GTA (AHI

> 32). Absolute gains in QALYs were found to follow a unimodal distribution

and were a function of disease severity. Those with mild or more severe

OSA had lower gains in QALYs, whereas the largest gains were observed in

patients whose baseline severity reduced from severe (AHI ≥ 30) or

moderate (15 < AHI < 30) to mild-to-moderate OSA (AHI < 30) or mild OSA

(AHI < 15), respectively, due to the impact on subsequent morbidity and

mortality risks. Incremental costs were largely driven by the costs of

treatment and long-term maintenance costs, given the longer life

expectancies of patients on treatment. The model was found to be most

sensitive to changes in treatment adherence.

Patient Perspectives and Experiences Evidence

A systematic review and thematic synthesis of the literature relevant to the

research question on patient experience and perspectives were conducted.

Patient experience information was identified by searching the following

databases: MEDLINE (1946–), Embase (1974–), and PsycINFO (1967–) via

Ovid; CINAHL (1981–) via EBSCO; and PubMed. Studies were eligible if

they presented the patient or non-clinical caregiver experience. Qualitative

studies, surveys, studies with mixed methodology, or systematic reviews of

descriptive studies were eligible. A maximum variation approach was used to

identify articles for inclusion in the thematic synthesis from a list of eligible

articles. A thematic synthesis was conducted, comprising three stages:

coding, developing descriptive themes, and developing analytic themes.


Thirty-two studies were included in the thematic synthesis, the coding and

analysis of which led to two analytic themes. The first theme described a

range of characteristics and factors that influence whether people seek and

initiate OSA treatment. Patients are influenced by the information they have

on therapy, any disability they may have, whether they receive support for

complying with the intervention, and their current life situation. The second

analytic theme centred on the finding that interventions for OSA require

adaptation to daily routines and relationships; some patients can integrate

these interventions into their life and experience benefits, while others are

unable to do so. Some patients are noncompliant to therapy for a variety of

reasons, each of which is personal and contextual to the individual. Patients

reported some degree of discomfort for all interventions, and this discomfort

may change over time as patients become accustomed to the device, or

recover from surgery.

Ethical Issues

A systematic review of the normative bioethics literature was conducted to

identify literature relevant to the identification and analysis of the potential

ethical issues on interventions for OSA (i.e., articles that explicitly and

specifically raise ethical issues). Targeted literature searches were

performed by a CADTH Information Specialist in MEDLINE, PubMed, and

CINAHL from database inception to March 2016. Key terms for ethics

concepts and related terms were used and combined with search terms for

OSA. The search was limited to English- or French-language literature.

The literature search yielded 1,268 unique citations, none of which passed

the first stage of screening because no articles on OSA treatment were

found that explicitly mentioned ethical issues. However, in the second stage,

the reviewers selected 142 potentially relevant articles that raised implicit

ethical issues. Ethical issues relating to OSA were explored according to six

key values that emerged from the literature review. The six key values were:

respect individual autonomy, maximize benefits and minimize harm for

patients, maximize benefits and minimize harms for others affected by OSA,

maximize benefits and minimize harms for populations, distribute benefits

and burdens of health care resources fairly, and steward scarce resources.

In terms of whether universal treatments for OSA should be implemented,

they have been shown to offer benefits to OSA patients and reduce overall

costs, and so appear to live up to values of conferring a benefit at a

population level and stewarding scarce resources. Further, optimizing

interventions for OSA to minimize harmful outcomes on both an individual

and at the population level is of great benefit, given variability in adherence

based on patient behaviours and attitude. To maximize overall benefit, OSA

treatment should be provided through an ongoing partnership between

health care provider and patient, rather than through discrete events of

diagnosis, decision, and intervention.


Implementation Issues

A narrative literature review was conducted to identify some of the

implementation issues associated with the different interventions for the

treatment of OSA in adults. Citations arising from the literature searches

conducted to address the clinical and economic effectiveness, patient

perspectives and experience, and ethical issues were screened

independently and in duplicate for information related to implementation

issues. Issues identified from relevant studies are organized by OSA

intervention (i.e., PAP devices, expiratory PAP valves, oral appliances,

surgical interventions, and lifestyle modifications) and further categorized by

the level where the issue arises: individual, team, organization, or system or

policy. This information was summarized narratively.

From the 27 included studies, one of the biggest implementation issues

identified for OSA treatment is difficulty accessing sleep specialists and

specialized sleep labs. Home-based portable diagnostic devices and

treatment titration options with telehealth-based support are suggested

solutions. Most of the implementation evidence focuses on CPAP devices.

Barriers to CPAP use include cost and lack of funding as well as patient

discomfort or use problems. Suggested CPAP supports include patient

education and training, as well as providers and centres that are accredited

for the treatment of OSA. Barriers to treatment with oral appliances include

lack of physician knowledge and awareness, anatomical and dental health

requirements, and the need for regular re-evaluations. Little evidence on

implementation issues for OSA surgery or lifestyle interventions was found.

Environmental Impact

Citations arising from the clinical literature search were screened for

information relating to environmental considerations associated with

obstructive sleep apnea.

One narrative review article identified the environmental implications

associated with OSA. The article briefly examined the environmental

considerations of the CPAP unit, including manufacturers adopting green

shipping and production methods, creating more energy-efficient products,

and using more recyclable materials.

Research Gaps

Additional research is needed to address patient characteristics that guide

the selection of interventions. There is a dearth of evidence on comorbidities

and outcomes of the interventions based on patient characteristics.

Research on direct, head-to-head comparisons or network meta-analyses on

the clinical effectiveness and safety of various treatments, and the impact of

these interventions in subgroups of OSA patients who have hypertension or

cardiovascular disease on the primary outcome and OSA severity, is also

warranted.


Research on OSA treatment for several subgroups, including Indigenous

populations, and populations with specific work occupations (e.g., military or

law enforcers), is underrepresented in the literature. Further research on

these subgroups may provide insight on the most effective treatments, given

their living conditions and life situations. Studies on the diagnosis of OSA in

women are necessary to assess whether OSA is underdiagnosed, less

common, or misdiagnosed among the female population. For instance, there

are differences in how men and women describe their symptoms, which may

lead to misdiagnosis in women.

Education of primary care clinicians on all the available interventions is

necessary, and research on adherence, especially its change with time and

relationship with the effectiveness of various treatment interventions,

comparative data across treatment interventions, and factors that influence

it, is merited. There is also a need for work to evaluate shared decision-

making and decision aids in OSA.


References

1. What is the impact of sleep apnea on Canadians? Fast facts from the 2009 Canadian community health survey - sleep apnea rapid response [Internet]. Ottawa: Public Health Agency of Canada; 2010. [cited 2016 Nov 30]. Available from: http://www.phac-aspc.gc.ca/cd-mc/sleepapnea-apneesommeil/pdf/sleep-apnea.pdf

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https://www.inesss.qc.ca/fileadmin/doc/INESSS/Rapports/MaladiesRespiratoires/INESSS_Politiques_remboursement_AOS_.pdf

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2858234


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https://www.nice.org.uk/guidance/ta139

http://annals.org/article.aspx?articleid=1742606


http://www.ncbi.nlm.nih.gov/books/NBK262704/pdf/Bookshelf_NBK262704.pdf


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https://www.cadth.ca/interventions-obstructive-sleep-apnea

https://www.cadth.ca/interventions-obstructive-sleep-apnea

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3070752/


http://www.aimspecialtyhealth.com/clinical-guidelines/agreementAccess-sleep

https://www.cdsbc.org/CDSBCPublicLibrary/Obstructive-Sleep-Apnea.pdf



http://www.health.alberta.ca/documents/AHTDP-Sleep-UofA-2013.pdf




Appendix 1: HTERP

HTERP consists of up to seven core members appointed to serve for all

topics under consideration during their term of office, and up to five expert

members appointed to provide their expertise for a specific topic. For this

project, three expert members were appointed; their expertise included

internal medicine, clinical chemistry, pathology, and family medicine. The

core members include health care practitioners and other individuals with

expertise and experience in evidence-based medicine, critical appraisal,

health technology assessment, bioethics, and health economics. One public

member is also appointed to the core panel to represent the broad public

interest.

HTERP is an advisory body to CADTH and is convened to develop guidance

or recommendations on non-drug health technologies to inform a range of

stakeholders within the Canadian health care system. Further information

regarding HTERP is available at www.cadth.ca/en/advisory-bodies/health-

technology-expert-review-panel.

HTERP Core Members

Dr. Stirling Bryan (Chair)

Dr. Jenny Basran

Dr. Leslie Anne Campbell

Dr. Hilary Jaeger

Dr. Jeremy Petch

Dr. Lisa Schwartz

Ms. Tonya Somerton

Expert Members

Dr. Sachin Pendharkar

Dr. Najib Ayas

Dr. Jessica Otte

Conflict of Interest

No members declared any conflicts of interest. Conflict of Interest Guidelines

are posted on the CADTH website.

http://www.cadth.ca/en/advisory-bodies/health-technology-expert-review-panel

http://www.cadth.ca/en/advisory-bodies/health-technology-expert-review-panel

http://www.cadth.ca/en/cadth/conflict-of-interest


Appendix 2: HTERP Deliberative Framework

Table 1: HTERP Deliberative Framework for Interventions for Obstructive Sleep Apnea

Framework Domain Examples of Information and Element(s)

Possible HTERP Discussion Question(s)

Discussion Points

Background/Context Audience; issue and policy question(s)

Who requested this assessment? Why?

Need for evidence-informed selection of OSA intervention based on patient characteristics.

Identify considerations for prioritization of patients, when device supplies are limited.

Implementation of an efficient, respectful, and equitable OSA care pathway.

Need Background on health condition Size of affected population

What condition does this health technology address? How many patients could potentially be affected?

3% of adult population is diagnosed with OSA; 17% to 25% are suspected to be or are at risk (i.e., age, male sex, obesity risk factors).

Availability of alternatives Are there existing therapeutic/diagnostic technologies that address the same problem?

PAP reimbursement varies across jurisdictions (i.e., partial to complete coverage).

Dental devices coverage varies.

Surgery may be covered as a medical act.

Benefits Efficacy Clinical effectiveness Impact on patient-centred outcomes Impact on clinical management Non-health benefits (e.g., patient autonomy, dignity)

Has the clinical effectiveness of the candidate technology been established? Compared with what? What improvements does this technology purport to offer over others? What types of evidence is this based on? Are we aware of any better-quality evidence likely to be produced in the near future?

For severe OSA, CPAP more effective than MADs for excessive daytime sleepiness.

For severe OSA, MMA ± GTA most effective if PAP therapies failed (Note: outcomes were derived from small, uncontrolled studies).

For other OSA severities, all interventions similarly effective.

CPAC is superior for reducing OSA severity.

Limited evidence on blood pressure, cardiovascular events, QoL, mortality outcomes is available.




Discussion Points

Are there any non-health benefits?

Some literature is of high quality but there are concerns with regards to the eligibility criteria, small samples, and uncontrolled studies.

Harms Safety What is known about safety in absolute terms, and in comparison with existing technologies? What types of evidence is this based on?

No major adverse events were reported, except MMA + GTA, with which all patients had complications caused by infections.

Patient Preferences Acceptability of health technology by the patient

How will it potentially affect patients and what are their opinions about the technology? How acceptable is it to patients?

Patient factors are individualized and contextual.

OSA affects bed partners. Patients perform a trade-off between the benefits of using interventions and their discomfort.

Elements of support and information are needed.

No evidence on patient experience with surgery was identified.

Economic Impact Cost-effectiveness Infrastructure support costs Budget impact

What will the technology cost (including initial purchase price and consumables, maintenance, and training of personnel)? Is there evidence of value for money? How is value defined? What is the expected lifespan and total budget impact of the technology?

PAP or MMA is the most cost-effective for severe OSA with a baseline AHI at a WTP of $50,000/QALY.

MAD or MMA is most cost-effective for moderate OSA.

No treatment is most cost-effective for mild OSA.

Implementation Integration of technology into existing workflow Training/competency requirements Repair and maintenance

Have issues of implementation of the technology in a real-world health system been identified and addressed?

One of the biggest implementation issues for OSA treatment is the difficulties in accessing sleep specialists and specialized sleep labs.

Most of the implementation evidence focuses on CPAP.

CPAP barriers include cost or lack of funding, patient discomfort or difficulties using the device.




Discussion Points

CPAP enablers encompass patient education, training, or support accredited sleep centres or health care professionals, but there are no accepted guidelines.

OA barriers include lack of knowledge or awareness, anatomical and dental health. requirements, need for regular re-evaluations.

OA enablers encompass multidisciplinary sleep clinics.

Little evidence on implementation issues for OSA surgery or lifestyle interventions was found.

Legal Legal impacts Are there potential legal or regulatory aspects to the introduction and use of this technology?

The legal issues associated with driving were discussed. For example, some jurisdictions can revoke a driver’s licence if the person has severe OSA.

The Canada Health Act does not include dentists.

Ethics Consistent with Canadian ethical values

Are there potential issues of equity (access by particular populations, for example) with respect to introducing this technology? Are there any other ethical issues to consider?

Interventions for OSA do not appear to present ethical concerns that are inherent to the technologies.

Several values are relevant on how access to OSA interventions are organized and delivered.

Duties to act in ways that maximize benefits to patients or others, respect patient choice, and ensure reasonable access to resources are of core importance.

The capacity for patients to benefit from most OSA interventions relies heavily on the patient’s behaviour, so patient context is perhaps unusually significant for these technologies.

Environmental Impact

Environmental impact of health technology

What is the potential impact on the environment of this technology?

One review article examined the environmental considerations of the CPAP unit including: o Green shipping and

production methods




Discussion Points

o Creating more energy-efficient products

o Using more recyclable materials.

Other Are there particular questions with regards to professional fees that have been identified and addressed? Does this candidate technology raise some questions that are not addressed by the above set of questions?

Compliance, adherence, and patient acceptability of the various treatment options.

Accurate diagnosis is necessary before appropriate treatment can be given.

AHI = apnea-hypopnea index; CPAP = continuous positive airway pressure; GTA = genial tubercle advancement; HTERP = Health Technology Expert

Review Panel; MAD = mandibular advancement device;

MMA = maxillomandibular advancement; OA = oral appliance; OSA = obstructive sleep apnea; PAP = positive airway pressure; QALY = quality-adjusted

life year; QoL = quality of life; WTP = willingness to pay.

interventions for the treatment of obstructive sleep apnea ...€¦ · osa obstructive sleep apnea...

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